Pneumococcal Disease
Conditions
Brief summary
This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age
Interventions
BIOLOGICAL20vPnC
20-valent pneumococcal conjugate vaccine
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female children ≥15 months to \<18 years of age at the time of consent. * Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. * For children \<5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered \>2 months before enrolment into the study
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) * Major known congenital malformation or serious chronic disorder * Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results * Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation * Cohorts 3 and 4: Pregnant or breastfeeding female participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was \>1. |
| Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Within 7 days after vaccination on Day 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. |
| Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Within 7 days after vaccination on Day 1 | Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Within 7 days after vaccination on Day 1 | Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination | From vaccination (on Day 1) up to 1 month after vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination | From vaccination (on Day 1) up to 6 months after vaccination | An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination | From vaccination (on Day 1) up to 6 months after vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method. |
| Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was \>1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | At 1 Month after vaccination on Day 1 | Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (\>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with \>=4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. OPA titers were measured in a randomized subset of samples in Cohort 2 for this outcome measure. |
| Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before vaccination and 1 month after vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution). |
| GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). |
| GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). |
| Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before vaccination on Day 1 and 1 month after vaccination | Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers were measured in a randomized subset of serum samples in Cohorts 1 and 2. OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4. |
| GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers measured in a randomized subset of serum samples in Cohorts 1 and 2 for this outcome measure. |
| GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Before vaccination on Day 1 to 1 month after vaccination | Pneumococcal serotype-specific OPA titers were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4. |
Countries
United States
Participant flow
Pre-assignment details
A total of 839 participants were enrolled and assigned to receive a single dose of 20-valent pneumococcal conjugate vaccine (20vPnC) of which 8 participants were not vaccinated and 831 were vaccinated with 20vPnC.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study. | 210 |
| Cohort 2: 20vPnC: >=2 to <5 Years Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study. | 219 |
| Cohort 3: 20vPnC: >=5 to <10 Years Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | 203 |
| Cohort 4: 20vPnC: >=10 to <18 Years Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | 207 |
| Total | 839 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 | 2 | 0 |
| Overall Study | No longer met eligibility criteria | 1 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Cohort 4: 20vPnC: >=10 to <18 Years | Cohort 3: 20vPnC: >=5 to <10 Years | Cohort 2: 20vPnC: >=2 to <5 Years | Cohort 1: 20vPnC: >=15 to <24 Months |
|---|---|---|---|---|---|
| Age, Customized 12 Years to 18 Years | 156 Participants | 156 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 28 Days to 23 Months | 210 Participants | 0 Participants | 0 Participants | 0 Participants | 210 Participants |
| Age, Customized 2 Years to 5 Years | 247 Participants | 0 Participants | 28 Participants | 219 Participants | 0 Participants |
| Age, Customized 6 Years to 11 Years | 226 Participants | 51 Participants | 175 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 158 Participants | 45 Participants | 32 Participants | 46 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 676 Participants | 161 Participants | 169 Participants | 173 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 91 Participants | 17 Participants | 22 Participants | 26 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 38 Participants | 9 Participants | 5 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 700 Participants | 180 Participants | 176 Participants | 175 Participants | 169 Participants |
| Sex: Female, Male Female | 389 Participants | 91 Participants | 94 Participants | 111 Participants | 93 Participants |
| Sex: Female, Male Male | 450 Participants | 116 Participants | 109 Participants | 108 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 216 | 0 / 201 | 0 / 205 |
| other Total, other adverse events | 173 / 209 | 163 / 216 | 178 / 201 | 186 / 205 |
| serious Total, serious adverse events | 2 / 209 | 0 / 216 | 0 / 201 | 3 / 205 |
Outcome results
Primary
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was \>1.
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: Evaluable immunogenicity population (EIP) included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 11A | 62.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 15B | 52.1 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 10A | 83.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 22F | 1847.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 12F | 27.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 33F | 113.5 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 8 | 113.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 33F | 78.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 8 | 107.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 10A | 106.7 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 11A | 43.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 12F | 36.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 15B | 73.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 | Serotype 22F | 796.2 Fold rise |
Primary
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was \>1.
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 11A | 11.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 15B | 380.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 10A | 30.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 22F | 128.5 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 12F | 463.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 33F | 14.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 8 | 106.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 33F | 11.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 8 | 86.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 10A | 33.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 11A | 14.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 12F | 454.1 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 15B | 499.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 | Serotype 22F | 111.2 Fold rise |
Primary
Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From vaccination (on Day 1) up to 1 month after vaccination
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination | 23.9 Percentage of participants | 95% Confidence Interval 18.3 |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination | 7.9 Percentage of participants | 95% Confidence Interval 4.7 |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination | 6.5 Percentage of participants | 95% Confidence Interval 3.5 |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination | 4.4 Percentage of participants | 95% Confidence Interval 2 |
Primary
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Time frame: From vaccination (on Day 1) up to 6 months after vaccination
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination | 3.3 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination | 0.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination | 0.5 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination | 1.0 Percentage of participants |
Primary
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, Number of Participants Analyzed signifies the number of participants with any electronic diary data after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 9.8 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 52.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 7.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 41.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Any | 37.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Any | 22.1 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Mild | 30.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 15.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 6.4 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Mild | 22.8 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.4 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 17.7 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Any | 23.3 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 66.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Any | 39.1 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 47.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 15.3 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 11.2 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.9 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 11.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Any | 37.2 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Mild | 16.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Severe | 2.0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Any | 27.1 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 10.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 15.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 1.0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 82.9 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 56.8 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 24.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 18.6 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 5.4 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Mild | 10.7 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 17.6 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.5 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Any | 15.6 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Any | 15.1 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 3.9 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 10.2 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 82.0 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.5 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 62.9 Percentage of participants |
Primary
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, Number of Participants Analyzed signifies the number of participants with any electronic diary data after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Fever: >=38.0 degrees C | 11.8 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Fever: >38.4 degrees C to 38.9 degrees C | 2.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Fever: >38.9 degrees C to 40.0 degrees C | 2.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Fever: >40.0 degrees C | 0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Decreased appetite: Any | 25.0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Drowsiness/increased sleep: Mild | 31.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Drowsiness/increased sleep: Severe | 1.0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Irritability: Any | 61.8 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Irritability: Moderate | 37.3 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Fever: >=38.0 degrees C to 38.4 degrees C | 5.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Decreased appetite: Mild | 17.6 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Decreased appetite: Moderate | 6.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Decreased appetite: Severe | 1.0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Drowsiness/increased sleep: Any | 41.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Drowsiness/increased sleep: Moderate | 9.3 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Irritability: Mild | 22.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 | Irritability: Severe | 2.0 Percentage of participants |
Primary
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, Number of Participants Analyzed signifies the number of participants with any electronic diary data after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Moderate | 1.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Moderate | 1.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Severe | 0.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.9 degrees C to 40.0 degrees C | 0.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Severe | 0.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Any | 5.6 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C to 38.4 degrees C | 1.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Moderate | 8.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Mild | 3.3 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Mild | 17.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Mild | 2.3 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >40.0 degrees C | 0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C | 3.3 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Any | 3.7 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Any | 37.2 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Severe | 0 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Any | 26.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Mild | 21.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.4 degrees C to 38.9 degrees C | 1.4 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Severe | 0.5 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Moderate | 14.4 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C | 0.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C to 38.4 degrees C | 0.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >40.0 degrees C | 0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Any | 28.1 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Mild | 19.1 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Moderate | 8.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Severe | 0.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Any | 18.6 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Mild | 26.6 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Moderate | 11.1 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Severe | 1.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Mild | 14.6 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Moderate | 3.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Severe | 1.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Any | 39.2 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Any | 6.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Mild | 3.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Moderate | 3.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Severe | 0.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Moderate | 12.2 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Moderate | 7.8 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Mild | 15.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Severe | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Severe | 1.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Any | 27.8 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Moderate | 4.9 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >40.0 degrees C | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C to 38.4 degrees C | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Any | 48.3 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Any | 8.3 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Mild | 34.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Any | 29.3 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Moderate | 13.2 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fatigue: Severe | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Fever: >=38.0 degrees C | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Muscle pain: Severe | 0.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Joint pain: Mild | 3.4 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 | Headache: Mild | 20.0 Percentage of participants |
Primary
Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination
An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Time frame: From vaccination (on Day 1) up to 6 months after vaccination
Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination | 1.0 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination | 0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination | 0 Percentage of participants |
| Cohort 4: 20vPnC: >=10 to <18 Years | Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination | 1.5 Percentage of participants |
Secondary
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Time frame: Before vaccination and 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or within 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants included in the EIP and Number Analyzed signifies participants with valid IgG concentrations at the specified timepoint for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 1.53 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 2.70 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 0.71 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 1.61 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 0.02 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 3.53 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 1.17 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 7.59 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 0.22 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 4.27 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 0.85 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 0.43 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 1.91 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 0.01 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 1.61 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 1.46 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 33F | 0.02 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 1.23 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 4.66 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 0.14 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 0.03 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 0.04 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 5.35 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 0.54 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 0.01 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 0.96 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 4.16 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 0.61 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 9.57 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 0.80 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 3.29 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 2.59 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 22F | 0.01 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 0.47 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 2.69 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 0.43 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 1.17 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 0.65 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 4.42 Micrograms per milliliter |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 1.53 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 5.09 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 0.38 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 0.20 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 4.21 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 0.08 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 1.21 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 0.30 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 8.37 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 0.18 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 0.71 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 31.99 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 0.52 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 17.78 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 0.51 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 6.42 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 0.35 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 7.94 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 0.66 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 14.60 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 0.26 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 7.07 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 0.52 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 12.48 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 0.56 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 12.50 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 0.90 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 16.18 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 0.05 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 5.08 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 0.03 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 2.76 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 0.06 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 2.64 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 0.01 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 0.05 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 3.96 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 22F | 0.02 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 12.46 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 33F | 0.04 Micrograms per milliliter |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 3.16 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 4.65 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 0.96 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 3.87 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 0.07 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 0.78 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 5.86 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 0.36 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 0.07 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 0.12 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 14.62 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 10.83 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 1.32 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 15.68 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 0.26 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 33F | 0.10 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 46.28 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 2.80 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 32.45 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 0.82 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 0.20 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 13.65 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 0.18 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 10.74 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 0.50 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 0.12 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 7.92 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 22.69 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 28.54 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 0.22 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 0.14 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 3.98 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 7.50 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 0.01 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 10.86 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 0.08 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 0.12 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 0.13 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 0.42 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 9.76 Micrograms per milliliter |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 22F | 0.08 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 0.04 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 28.17 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 0.28 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 0.13 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 6.37 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 12.36 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 8.61 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 0.55 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 0.12 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 8.89 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 0.35 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 0.82 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 0.62 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 18.79 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 6.55 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 0.61 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 0.15 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 19.16 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 0.16 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 4.04 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 4.26 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 22F | 0.14 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 0.15 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 3.93 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 0.30 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 0.09 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 20.03 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 0.40 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 38.82 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 0.28 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 3.13 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 0.11 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 3.19 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 2.58 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 5.35 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 0.14 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 7.67 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 0.01 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 0.29 Micrograms per milliliter |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 33F | 0.18 Micrograms per milliliter |
Secondary
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers were measured in a randomized subset of serum samples in Cohorts 1 and 2. OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
Time frame: Before vaccination on Day 1 and 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants with valid OPA titers at the specified timepoint for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 3749 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 14 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 1707 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 92 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 300 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 1936 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 110 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 51 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 80 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 1018 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 943 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 30 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 242 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 7686 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 705 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 13350 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 649 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 57 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 2635 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 10626 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 18 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 22951 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 4758 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 139 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 267 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 22F | 21 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 30 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 44 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 42 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 22464 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 38 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 1708 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 137 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 33F | 1154 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 88 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 138 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 563 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 23431 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 16924 Titer |
| Cohort 1: 20vPnC: >=15 to <24 Months | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 21 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 436 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 14345 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 17 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 14093 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 37 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 13257 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 111 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 198 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 27095 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 22F | 104 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 25573 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 33F | 2179 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 96 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 28076 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 5283 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 12 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 126 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 3273 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 996 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 360 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 323 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 7210 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 3409 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 300 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 15 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 2506 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 139 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 150 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 5344 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 84 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 2640 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 44 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 34 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 928 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 206 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 2493 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 39 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 1729 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 4428 Titer |
| Cohort 2: 20vPnC: >=2 to <5 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 275 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 48 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 74 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 15 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 6766 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 155 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 33F | 3334 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 21102 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 117 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 2213 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 33615 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 34 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 2162 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 45921 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 22F | 259 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 1347 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 91 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 16882 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 385 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 745 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 3981 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 1095 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 541 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 43 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 410 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 548 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 29 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 25729 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 11717 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 3870 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 6569 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 87 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 246 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 79 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 10 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 23860 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 4610 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 156 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 8268 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 2328 Titer |
| Cohort 3: 20vPnC: >=5 to <10 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 152 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 33F | 32363 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 3 | 19 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 1 | 11 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 1 | 396 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 3 | 105 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 4 | 34 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 4 | 2290 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 5 | 15 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 5 | 216 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6A | 64 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6A | 9434 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 6B | 237 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 6B | 10085 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 7F | 516 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 7F | 3326 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 9V | 469 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 9V | 9627 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 14 | 97 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 14 | 3925 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 18C | 73 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 18C | 3617 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19A | 66 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19A | 2212 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 19F | 57 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 19F | 551 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 23F | 46 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 23F | 1842 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 8 | 35 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 8 | 3125 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 10A | 554 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 10A | 17417 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 11A | 765 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 11A | 11677 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 12F | 46 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 12F | 20250 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype 15B | 45 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 15B | 21496 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 22F | 243 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | 1 Month after Vaccination, Serotype 22F | 27922 Titer |
| Cohort 4: 20vPnC: >=10 to <18 Years | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | Before Vaccination, Serotype: 33F | 2895 Titer |
Secondary
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 4 | 4.3 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 9V | 3.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 6A | 4.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 14 | 2.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 3 | 3.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 18C | 4.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 6B | 5.0 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 19A | 6.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 5 | 3.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 19F | 5.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 7F | 3.0 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 23F | 5.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 1 | 3.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 23F | 17.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 1 | 20.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 3 | 14.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 4 | 27.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 5 | 28.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 6A | 44.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 6B | 34.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 7F | 12.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 9V | 23.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 14 | 22.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 18C | 27.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 19A | 24.1 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 | Serotype 19F | 22.3 Fold rise |
Secondary
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants included in the EIP and Number Analyzed signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 6B | 127.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 19A | 17.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 33F | 39.3 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 1 | 49.4 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 3 | 5.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 4 | 74.1 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 5 | 107.0 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 6A | 91.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 7F | 42.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 9V | 80.3 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 14 | 68.4 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 18C | 93.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 19F | 15.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 23F | 27.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 8 | 55.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 10A | 54.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 11A | 23.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 12F | 31.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 15B | 52.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 22F | 187.7 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 15B | 53.8 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 18C | 64.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 19A | 16.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 11A | 10.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 1 | 44.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 19F | 8.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 3 | 4.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 33F | 22.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 4 | 52.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 23F | 31.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 5 | 59.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 12F | 21.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 6A | 72.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 6B | 99.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 8 | 27.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 7F | 30.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 22F | 86.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 9V | 54.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 10A | 35.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 | Serotype 14 | 96.7 Fold rise |
Secondary
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Pneumococcal serotype-specific OPA titers were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 4 | 50.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 9V | 28.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 6A | 110.3 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 14 | 18.1 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 3 | 5.3 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 18C | 46.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 6B | 38.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 19A | 17.5 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 5 | 26.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 19F | 11.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 7F | 7.0 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 23F | 26.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 1 | 55.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 23F | 39.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 1 | 37.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 3 | 5.8 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 4 | 65.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 5 | 14.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 6A | 147.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 6B | 42.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 7F | 6.2 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 9V | 20.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 14 | 38.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 18C | 47.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 19A | 33.1 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 | Serotype 19F | 10.0 Fold rise |
Secondary
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers measured in a randomized subset of serum samples in Cohorts 1 and 2 for this outcome measure.
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 4 | 13.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 19A | 11.1 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 6B | 7.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 19F | 5.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 3 | 3.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 23F | 12.5 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 7F | 3.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 8 | 155.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 10A | 121.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 5 | 2.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 11A | 161.4 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 9V | 11.5 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 12F | 437.2 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 1 | 4.1 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 15B | 717.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 14 | 3.9 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 22F | 983.6 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 6A | 12.7 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 33F | 18.8 Fold rise |
| Cohort 1: 20vPnC: >=15 to <24 Months | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 18C | 12.7 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 33F | 12.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 1 | 29.8 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 3 | 9.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 4 | 50.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 5 | 11.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 6A | 52.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 6B | 24.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 7F | 3.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 9V | 23.1 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 14 | 8.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 18C | 40.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 19A | 33.5 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 19F | 21.0 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 23F | 10.7 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 10A | 53.3 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 11A | 34.7 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 12F | 319.9 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 15B | 294.4 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 22F | 224.6 Fold rise |
| Cohort 2: 20vPnC: >=2 to <5 Years | GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 | Serotype 8 | 105.4 Fold rise |
Secondary
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with \>=4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. OPA titers were measured in a randomized subset of samples in Cohort 2 for this outcome measure.
Time frame: Before vaccination on Day 1 to 1 month after vaccination
Population: EIP included all participants who were eligible; received 20vPnC;at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohort 2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants with valid assay results at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 10A | 84.9 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 15B | 88.2 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 12F | 94.6 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 8 | 93.2 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 33F | 71.2 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 22F | 86.8 Percentage of participants |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 11A | 86.5 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 12F | 96.8 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 8 | 92.2 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 10A | 80.6 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 11A | 66.2 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 15B | 89.4 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 22F | 87.6 Percentage of participants |
| Cohort 2: 20vPnC: >=2 to <5 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 33F | 79.9 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 15B | 93.9 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 10A | 81.7 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 33F | 75.3 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 22F | 81.0 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype: 12F | 94.5 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 11A | 62.6 Percentage of participants |
| Cohort 3: 20vPnC: >=5 to <10 Years | Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only | Serotype 8 | 89.1 Percentage of participants |
Secondary
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (\>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method.
Time frame: At 1 Month after vaccination on Day 1
Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohort 1; no other major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 8 | 100.0 Percentage of participants | 95% Confidence Interval 98.1 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 10A | 83.2 Percentage of participants | 95% Confidence Interval 77.1 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 11A | 93.2 Percentage of participants | 95% Confidence Interval 88.6 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 12F | 40.0 Percentage of participants | 95% Confidence Interval 33 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 15B | 83.7 Percentage of participants | 95% Confidence Interval 77.6 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 22F | 98.9 Percentage of participants | 95% Confidence Interval 96.2 |
| Cohort 1: 20vPnC: >=15 to <24 Months | Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only | Serotype 33F | 92.6 Percentage of participants | 95% Confidence Interval 87.9 |